Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial
NCT ID: NCT04300920
Last Updated: 2025-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
202 participants
INTERVENTIONAL
2020-12-17
2026-02-27
Brief Summary
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The secondary objectives will be to examine the effect of NAC on the components of the primary composite endpoint, the rates of clinical events, change in physiology, change in health status, and change in respiratory symptoms.
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Detailed Description
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Eligible participants will be randomized in a 1:1 fashion to NAC or placebo, stratified by stable concomitant IPF therapy use (i.e., pirfenidone or nintedanib administered for at least 6 weeks prior to screening) versus no pirfenidone or nintedanib use. Participants will receive 600 mg NAC orally or matched placebo to take three times daily for 24 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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N-acetylcysteine
600 mg oral N-acetylcysteine (NAC) three times daily for 24 months.
N-acetyl cysteine
600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.
Placebo
Placebo tablet three times daily for 24 months.
Placebo
Matching oral placebo tablet three times daily for 24 months.
Interventions
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N-acetyl cysteine
600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.
Placebo
Matching oral placebo tablet three times daily for 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with IPF according to 2018 ATS/ERS/JRS/ALAT, confirmed by enrolling investigator
* Signed informed consent
* If taking pirfenidone or nintedanib, must be on stable dose for at least 6 weeks prior to enrollment visit
* Confirmed rs3570920 TT TOLLIP genotype
Exclusion Criteria
* Women of childbearing potential not willing to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year during study participation
* Significant medical, surgical or psychiatric illness that in the opinion of the investigator would affect subject safety, including liver and renal failure
* Receipt of an investigational drug or biological agent within the previous 4 weeks of the screening visit or 5 times the half-life, if longer
* Supplemental or prescribed NAC therapy within 60 days of enrollment
* Listed for lung transplantation at the time of screening
* History of lung cancer
* Inability to perform spirometry
* Forced vital capacity (FVC) less than 45% predicted, using the global lung function index (GLI) equation at Visit 1
* Active respiratory infection requiring treatment with antibiotics within 4 weeks of Visit 1
40 Years
ALL
No
Sponsors
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University of Virginia
OTHER
University of Michigan
OTHER
Pulmonary Fibrosis Foundation
OTHER
University of Washington
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Three Lakes Foundation
UNKNOWN
Fernando J Martinez
OTHER
Responsible Party
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Fernando J Martinez
Professor
Principal Investigators
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Fernando J Martinez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts Chan Medical School
Imre Noth, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Kevin Flaherty, MS, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Cathie Spino, ScD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Arizona
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Stanford University
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Piedmont Healthcare
Austell, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Loyola University
Maywood, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Tulane University
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Weill Cornell Medicine
New York, New York, United States
University of Rochester
Rochester, New York, United States
Ohio State University
Columbus, Ohio, United States
Temple University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Lisa Lancaster
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas Health San Antonio
San Antonio, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Podolanczuk AJ, Kim JS, Cooper CB, Lasky JA, Murray S, Oldham JM, Raghu G, Flaherty KR, Spino C, Noth I, Martinez FJ; PRECISIONS Study Team. Design and rationale for the prospective treatment efficacy in IPF using genotype for NAC selection (PRECISIONS) clinical trial. BMC Pulm Med. 2022 Dec 13;22(1):475. doi: 10.1186/s12890-022-02281-8.
Other Identifiers
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19-12021232
Identifier Type: -
Identifier Source: org_study_id
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